SEC Company Response from ABBOTT LABORATORIES (ABT) — Jun 30, 2010
ABBOTT LABORATORIES
Date: June 30, 2010 · CIK: 0000001800 · Accession: 0001104659-10-036465
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File numbers found in text: 001-02189
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CORRESP 1 filename1.htm June 30, 2010 Mr. James Rosenberg Senior Assistant Chief Accountant United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street NE Washington, D.C. 20549 RE: File Number 001-02189 Dear Mr. Rosenberg: In reply to your letter of June 16, 2010, we have enclosed our response in the attachment to this letter. As per your request, Abbott acknowledges that we are responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and Abbott may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Very truly yours, /s/ Thomas C. Freyman Thomas C. Freyman Executive Vice President, Finance and Chief Financial Officer Enclosure Abbott Laboratories Form 10-K for Fiscal Year ended December 31, 2009 Definitive Proxy Statement on Schedule 14A Filed March 15, 2010 File No. 001-02189 Form 10-K for the fiscal year ended December 31, 2009 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Financial Review, page 26 1. Refer to your response and proposed disclosure to our comment two. · Please revise your proposed disclosure to indicate which projects are individually material. Indicate in your disclosure both the qualitative and quantitative factors that you considered in making this determination. For those projects that are individually material, please revise to disclose all the information listed in our prior comment two. If information is not obtainable or if an amount or range of amounts cannot be estimated, specify in your disclosure which is the case, and disclose why. We believe that this information is material to investors and unless you can demonstrate otherwise, we do not believe that it should be excluded based on your assertion that it would be detrimental to the company’s competitive position. · Regarding your projects in the aggregate, please revise to disclose as part of the disclosure that you have proposed: · Whether the cost to complete projects is expected to be material. If so, disclose the estimated costs or a range of costs to complete such as a minimum and maximum amount to complete. To the extent that you cannot estimate some or any of these estimates, disclose the reason why. · If you do not believe or do not know whether your financial position will be adequate to finance the completion of your projects or you will need to seek financing to complete your projects, disclose which is the case and the expected effect on results of operations, financial position and liquidity. Response: Given the diversity of Abbott’s business, its intention to remain a broad-based healthcare company and the numerous sources for potential future growth, no individual project is expected to be material to cash flows or results of operations. Factors considered included R&D expenses projected 1 to be incurred for the project (compound or device) over the next year relative to Abbott’s total R&D spending as well as qualitative factors, such as marketplace perceptions and impact of a new product on Abbott’s overall market position. While the aggregate cost to complete our numerous pharmaceutical and medical device projects currently in development is expected to be material, the total cost to complete will depend upon Abbott’s ability to successfully complete each project, the rate at which each project advances, and the ultimate timing for completion. Given the potential for significant delays and the high rate of failure inherent in the research and development of new pharmaceutical and medical device products and technologies, it is not possible to accurately estimate the total cost to complete all projects currently in development. However, we plan to manage our portfolio of projects over the near-term to achieve R&D spend equal to approximately 9 - 10% of sales each year. We will include the statements above in our previously proposed disclosure. We believe that our financial position will be adequate to finance the completion of our R&D projects. Conclusion of TAP Pharmaceutical Products Inc. Joint Venture and Sale of Abbott’s Spine Business, page 33 2. It is unclear why a confidential treatment request was requested in response to our comments three and four. Please provide to us written substantiation in support of the need for confidential treatment of the information requested. In addition, please: · Resubmit your paper response and limit your Rule 83 request to only those portions of the response letter which must truly remain confidential; · Submit an electronic version of the response letter as CORRESP and include all the non-confidential information in that letter; and · Redact the information subject to the new Rule 83 request and mark the response letter using brackets or other clear markings to indicate the location of the omitted material. Response: Under the agreement to conclude the TAP Pharmaceutical Products, Inc. (TAP) joint venture, Abbott is required to collaborate in good faith with Takeda to obtain Takeda’s consent to any public disclosure with respect to the agreement. Abbott was not able to obtain Takeda’s consent in time to meet your request that our response to your April 22, 2010 letter be submitted within 10 business days. Therefore, we requested confidential treatment. Given that we have now obtained Takeda’s consent to publicly 2 disclose our response, we have included a copy of our previous paper response below so that it will be submitted electronically as CORRESP. Response previously provided on May 6, 2010: Conclusion of TAP Pharmaceutical Products Inc. Joint venture and Sale of Abbott’s Spine Business, page 33 3. You disclose that you receive payments from Takeda based on specified development, approval and commercial events being achieved with respect to products retained by Takeda and payments from Takeda based on sales of products retained by Takeda, which are recorded as Other (income) expense, net as earned. Please quantify the payments received and how these payments are recognized, as “as earned” is vague. Also, clarify the time period these payments will terminate. Response: Abbott received payments from Takeda totaling $244 million based on the following events, as specified in the agreement to conclude the TAP Pharmaceutical Products, Inc. (TAP) joint venture: · $71 million when a drug specified in the agreement was submitted by Takeda for FDA review and the New Drug Application (NDA) was not withdrawn within a specified time period, · $47 million when the above drug was approved by the FDA and launched for commercial sale in the U.S., · $71 million when Takeda initiated a Phase III study for another specified drug and the drug’s Investigational New Drug application (IND) was not withdrawn from the FDA within a specified time period, and · $55 million when the NDA for a third specified drug was approved by the FDA. Abbott recorded the above amounts as Other Income when the specified event was achieved. The agreement that concluded the TAP joint venture provides for 2 additional events, which if achieved, would result in the payment of additional milestones to Abbott. One event will not occur as product development was discontinued and the other event does not appear likely. If the latter event is not achieved, no additional accounting will be required for milestone payments. Additionally, Abbott received royalty payments of $48 million, $174 million, and $21 million in the last 8 months of 2008, calendar year 2009, and the first three months of 2010, respectively, based on sales of products retained by Takeda, primarily the drug Prevacid. Royalties are earned as Takeda sells Prevacid and other products and Abbott records these royalties as sales are made. Abbott is entitled to receive payments based on Takeda’s sales of 3 specified products through April 2013. However, the amounts have declined significantly in 2010 due to generic competition on Prevacid. In future Form 10-K filings, we will modify our disclosure to further explain “as earned”. The disclosure will state (change highlighted in bold): Abbott also receives payments based on specified development, approval and commercial events being achieved with respect to the products retained by Takeda and payments from Takeda based on sales of products retained by Takeda, which are recorded by Abbott as Other (income) expense, net when the specified event is achieved or as the applicable sales are made. 4. We also note that the payments you made to Takeda related to certain research and development events not achieved on the development assets retained by Takeda ceased in 2009. Please clarify why these payments ceased and no further payment is required which resulted in the company recognizing $797 million in other income. In your response, please explain to us why you accrued the original $1.1 obligation in 2008 and reference for us the authoritative literature you relied upon to support your accounting. Response: The agreement that concluded the TAP joint venture included terms related to the sale of Abbott’s equity interest in TAP whereby Abbott would pay specified amounts if specified development-stage drugs received by Takeda did not progress to a targeted result by a targeted date. Takeda reverted the license for one specified drug to the licensor after conclusion of the TAP joint venture and we were required to make payments to Takeda of $200 million and $83 million in 2008 and 2009, respectively. The 2008 and 2009 payments were charged against the original $1.1 billion obligation. Payments totaling an additional $797 million would have been required if FDA approval had not been obtained for two specified products within a targeted time period. Takeda obtained approval for the two products in 2009 and as a result, the payments were no longer required and the $797 million obligation was derecognized. Under ASC 450-30-25 (formerly paragraph 17 of FAS 5), “a contingency that might result in a gain usually should not be reflected in the financial statements because to do so might be to recognize revenue before its realization.” The contingent payments of $1.1 billion represent contingent gain on the exchange transaction. If we had not accrued the original $1.1 billion obligation in 2008, the exchange of Abbott’s investment in TAP for TAP’s Lupron business would have resulted in a larger gain at close and in the recording of a contingent gain. Under that accounting, when Abbott was required to make the payments of $200 million and $83 million that it made, Abbott would have been required to reverse the previously recorded gain related to the same matter. 4 Definitive Proxy Statement of Schedule 14A filed March 15, 2010 General 3. We note that you have not included any disclosure in response to Item 402(s) of Regulation S-K. Please advise us of the basis for your conclusion that disclosure is not necessary and describe the process you undertook to reach that conclusion. Response: Abbott did not include any disclosure in response to Item 402(s) of Regulation S-K based on the statement found on page 17 of Release No. 33-9089 (Proxy Disclosure Enhancements, dated February 28, 2010), which states, “the final rule does not require a company to make an affirmative statement that it has determined that the risks arising from its compensation policies and practices are not reasonably likely to have a material adverse effect on the company.” During 2009, Abbott, through its Human Resources department in coordination with Internal Audit, conducted a risk assessment of its compensation policies and practices for employees, including those related to its executive compensation programs. Abbott’s risk assessment included a qualitative and quantitative analysis of its employee compensation and benefit programs, including those for its executive officers. Abbott also considered how these programs compare, from a design perspective, to programs maintained by other companies. Based on this assessment, Abbott determined its compensation and benefit programs appropriately incent employees and any risks arising from its compensation policies and practices are not reasonably likely to have a material adverse effect on Abbott. The following factors were among those considered in making this determination: · Abbott’s long-established compensation structure has contributed to a corporate culture that encourages employees to regard Abbott as a career employer. For example, Abbott’s U.S. employees participate in an Abbott sponsored defined benefit pension plan. Equity awards (discussed in more detail below) also vest over multi-year periods. Both forms of compensation encourage Abbott employees to consider the long-term impact of their decisions and align their interests with those of Abbott’s shareholders. · Abbott’s long-term incentive program focuses executives on longer-term operating performance and shareholder returns. For 2009, Abbott’s officers received 64% of their total compensation in the form of long-term equity incentives (25% of which are stock options, vesting over multi-year periods and 75% of which are performance awards, which vest over a period of up to five years with not more than one- 5 third of the award vesting in any one year). Abbott’s officers do not receive any of their long-term incentive compensation in cash. · Abbott’s annual incentive program places an appropriate weighting on earnings achievement by balancing it with other factors, such as those described in this comment response. Since earnings are a key component of stock price performance, this aspect of Abbott’s compensation plan also promotes alignment with shareholder interests. · Abbott makes equity awards and sets grant prices at the same time each year, at the compensation committee’s regularly scheduled meeting. In addition, Abbott does not award discounted stock options or immediately vesting stock options or restricted stock. · Abbott has share ownership guidelines for its officers, which promotes alignment with shareholder interests. · Abbott’s compensation committee has the ability to exercise downward discretion in determining annual incentive plan payouts. Historically, and in 2009, the compensation committee exercised its discretion to deliver annual incentive plan awards below the maximums. · Abbott requires mandatory training on its codes of conduct and policies and procedures to educate its employees on appropriate behaviors and the consequences of taking inappropriate actions. · Abbott does not include certain design features that may have the potential to encourage excessive risk-taking, including: over-weighting toward annual incentives, highly leveraged payout curves, unreasonable thresholds, and steep payout cliffs at certain levels that may encourage short-term business decisions to meet payout thresholds. This assessment was discussed with the Compensation Committee’s independent compensation consultant, Hewitt Associates LLC, which agreed with Abbott’s conclusions and with the Compensation Committee. Hewitt also discussed Abbott’s compensation policies and practices, and informed the committee that the risks arising from Abbott’s compensation policies and practices are not reason